Puncture microneedle device adopting cannula inner core and used for precise administration through tympanic chamber of external auditory canal

Abstract

The invention provides an external auditory canal tympanic chamber precise administration puncture microneedle device adopting a cannula inner core. The external auditory canal tympanic chamber precise administration puncture microneedle device comprises a long-strip-shaped outer tube element and a long-strip-shaped inner core element. A first protrusion and a second protrusion are formed at the front end, inserted into the ear, of the long-strip-shaped outer pipe element, and a concave part between the first protrusion and the second protrusion is used for limiting the position of the tympanic membrane in the state that the first protrusion penetrates through the tympanic membrane. The long-strip-shaped outer pipe element is of a hollow structure, and a cavity for the long-strip-shaped inner core element to be inserted into the front end from the rear end is formed in the long-strip-shaped outer pipe element.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a microneedle device for precise drug delivery and puncture through the external auditory canal tympanic cavity using a cannula inner core. Background Art

[0002] At present, local treatment of inner ear diseases (such as deafness, tinnitus, vertigo, etc.) in clinical practice is mostly carried out by tympanic administration. Tympanic administration is a method of local treatment of inner ear diseases, mainly used in otology, especially for deafness, tinnitus and vertigo. This method directly delivers the drug to the tympanic cavity of the middle ear, allowing the drug to penetrate the round window membrane or oval window membrane, and then enter the perilymph of the inner ear, directly affecting the cochlea and vestibular organs.

[0003] There is no puncture needle designed specifically for tympanic drug delivery on the market. Therefore, it is desirable to develop a novel puncture needle device for tympanic drug delivery via the external auditory canal. Summary of the invention

[0004] The technical problem to be solved by the present invention is to provide a microneedle device for precise drug delivery through the external auditory canal tympanic cavity using a cannula inner core in view of the above-mentioned defects in the prior art, which is easy to operate and can achieve precise drug delivery.

[0005] According to the present invention, there is provided a microneedle device for precise drug delivery through the external auditory canal and tympanic cavity using a sleeve inner core, which is characterized in that it comprises: an elongated outer tube element and an elongated inner core element; wherein a first protrusion and a second protrusion are formed at the front end of the elongated outer tube element inserted into the ear, wherein the cross-sectional area of ​​the first protrusion gradually decreases from the back to the front so as to penetrate the tympanic membrane, and a recessed portion between the first protrusion and the second protrusion is used to limit the position of the tympanic membrane when the first protrusion penetrates the tympanic membrane; and the elongated outer tube element is a hollow structure, which forms a cavity for inserting the elongated inner core element from the rear end to the front end.

[0006] Preferably, the elongated inner core element has a front tip and a hand-held end; when the elongated inner core element is fully inserted into the elongated outer tube element, the front tip is exposed from the elongated outer tube element.

[0007] Preferably, when the elongated inner core element is completely inserted into the elongated outer tube element, the handheld end contacts the rear end of the elongated outer tube element.

[0008] Preferably, the cross-sectional area of ​​the handheld end is designed so that the handheld end cannot be inserted into the rear end of the elongated outer tube element.

[0009] Preferably, the elongated inner core element has a cavity for containing the drug, so as to assist in propulsion and achieve drug administration over a longer distance.

[0010] Preferably, the microneedle device for precise drug delivery through the external auditory canal tympanic cavity using a cannula inner core also includes: a foldable fixing wing located in the ear canal area of ​​the elongated outer tube element when the first protrusion penetrates the eardrum, for fixing the position of the elongated outer tube element in the ear canal.

[0011] Preferably, the microneedle device for precise drug delivery through the external auditory canal tympanic cavity using a cannula inner core further comprises: a control element arranged at the rear end of the elongated outer tube element for controlling the opening and folding of the foldable fixed wings.

[0012] Preferably, a tee is arranged at the tail end of the elongated outer tube element; wherein the first opening of the tee is connected to the hollow structure of the elongated outer tube element; the opening direction of the second opening of the tee is arranged in a straight line with the opening direction of the first opening, for insertion of the elongated inner core element; the third opening of the tee is used to connect the dosing unit.

[0013] Preferably, the first protrusion has a cross-sectional area that gradually decreases in a direction from back to front so as to penetrate the eardrum.

[0014] Preferably, the outer diameter of the elongated outer tube element is in the range of 0.1 to 0.5 mm, and the inner diameter is in the range of 0.05 to 0.3 mm; the material of the elongated outer tube element is medical plastic or medical silicone; the material of the elongated inner core element is medical hard plastic or stainless steel metal material, and the length of the main tube of the elongated outer tube element is in the range of 4.5 to 10 cm.

[0015] The present invention adopts a raised ultra-fine needle with two ribs at the front end, and is equipped with an inner core specially designed for microneedle implantation to play a boosting role. In addition, a foldable fixing wing is added to the ear canal area of ​​the microneedle for fixing the relative position in the ear canal, and a bifurcated double-branch structure is provided at the tail end of the microneedle to connect different drug delivery syringes, micropumps, drug delivery balloons, etc.

[0016] The invention is easy to operate, easy to fix, and has no adverse reactions such as obvious discomfort, which greatly improves the patient's compliance and the accuracy of sustained-release targeted drug delivery. At the same time, the invention has a low production cost and is suitable for large-scale production and promotion and application.

[0017] The invention is particularly suitable for local administration through the external auditory canal tympanic cavity, and has good application prospects and economic benefits for treating inner ear diseases such as deafness, tinnitus and vertigo. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] A more complete understanding of the present invention and its attendant advantages and features will be more readily appreciated by reference to the following detailed description taken in conjunction with the accompanying drawings, in which:

[0019] Figure 1The overall schematic diagram of the microneedle device for precise drug delivery through the external auditory canal tympanic cavity using a cannula inner core according to a preferred embodiment of the present invention is schematically shown.

[0020] Figure 2 A schematic diagram of a microneedle device for precise drug delivery through the external auditory canal tympanic cavity using a cannula inner core according to a preferred embodiment of the present invention is schematically shown in a state where the inner core is pushed.

[0021] It should be noted that the drawings are used to illustrate the present invention, rather than to limit the present invention. Note that the drawings showing the structures may not be drawn to scale. In addition, in the drawings, the same or similar elements are marked with the same or similar reference numerals. DETAILED DESCRIPTION

[0022] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0023] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0024] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0025] In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0026] Figure 1The overall schematic diagram of a microneedle device for precise drug delivery through the external auditory canal tympanic cavity using a cannula inner core according to a preferred embodiment of the present invention is schematically shown.

[0027] like Figure 1 As shown, the microneedle device for precise drug delivery through the external auditory canal tympanic cavity using a sleeve inner core according to a preferred embodiment of the present invention comprises: a long strip outer tube element 10 and a long strip inner core element 20.

[0028] A first protrusion 11 and a second protrusion 12 are formed at the front end of the long outer tube element 10 inserted into the ear, wherein the cross-sectional area of ​​the first protrusion 11 gradually decreases in the direction from back to front so as to penetrate the eardrum, and the recessed portion between the first protrusion 11 and the second protrusion 12 is used to limit the position of the eardrum 13 when the first protrusion 11 penetrates the eardrum.

[0029] Moreover, the long strip outer tube element 10 is a hollow structure, which forms a cavity for the long strip inner core element 20 to be inserted from the rear end (handheld end) to the front end (ear end).

[0030] Preferably, the elongated inner core element 20 has a front tip 21 and a hand-held end 22; when the elongated inner core element 20 is fully inserted into the elongated outer tube element 10, the front tip 21 is exposed from the elongated outer tube element 10, and the hand-held end 22 is in contact with the rear end of the elongated outer tube element 10, as shown in FIG. Figure 2 shown.

[0031] Specifically, the cross-sectional area of ​​the handheld end 22 is designed so that the handheld end 22 cannot be inserted into the rear end of the elongated outer tube element 10. In other words, for example, the cross-sectional area of ​​the handheld end 22 is larger than the cross-sectional area of ​​the rear end of the elongated outer tube element 10.

[0032] For example, preferably, the elongated inner core element 20 has a cavity for containing drugs, so as to assist in propulsion and achieve drug administration at a longer distance.

[0033] Preferably, if Figure 1 As shown, according to a preferred embodiment of the present invention, the microneedle device for precise drug delivery through the external auditory canal and tympanic cavity using a sleeve inner core also includes: a foldable fixing wing 14 located in the ear canal area of ​​the elongated outer tube element 10 when the first protrusion 11 penetrates the tympanic membrane, which is used to fix the position of the elongated outer tube element 10 in the ear canal.

[0034] Preferably, the microneedle device for precise drug delivery through the external auditory canal tympanic cavity using a cannula inner core according to a preferred embodiment of the present invention further comprises: a control element (not specifically shown) arranged at the rear end (handheld end) of the long strip outer tube element 10 for controlling the opening and folding of the foldable fixing wings 14. Thus, when it is determined that the predetermined position in the ear canal has been reached, the foldable fixing wings 14 can be opened to fix the position of the long strip outer tube element 10 in the ear canal.

[0035] Preferably, a tee 15 is arranged at the tail end of the elongated outer tube element 10; wherein the first opening of the tee 15 is connected to the hollow structure of the elongated outer tube element 10; the opening direction of the second opening of the tee 15 is arranged in a straight line with the opening direction of the first opening, for the insertion of the elongated inner core element 20; the third opening of the tee 15 is used to connect a dosing unit 16, such as a dosing syringe, a micropump, and a dosing balloon.

[0036] Preferably, the outer diameter of the microneedle body (long outer tube element 10) is in the range of 0.1 to 0.5 mm, and the inner diameter is in the range of 0.05 to 0.3 mm, that is, an ultrafine microneedle. The material of the long outer tube element 10 is, for example, medical plastic or medical silica gel; the material of the long inner core element 20 is, for example, medical hard plastic or stainless steel metal material, and the length of the main tube of the long outer tube element 10 is in the range of 4.5 to 10 cm.

[0037] The present invention adopts a raised ultra-fine needle with two ribs at the front end, and is equipped with an inner core specially designed for microneedle implantation to play a boosting role. In addition, a foldable fixing wing is added to the ear canal area of ​​the microneedle for fixing the relative position in the ear canal, and a bifurcated double-branch structure is provided at the tail end of the microneedle to connect different drug delivery syringes, micropumps, drug delivery balloons, etc.

[0038] The invention is easy to operate, easy to fix, and has no adverse reactions such as obvious discomfort, which greatly improves the patient's compliance and the accuracy of sustained-release targeted drug delivery. At the same time, the invention has a low production cost and is suitable for large-scale production and promotion and application.

[0039] The invention is particularly suitable for local administration through the external auditory canal tympanic cavity, and has good application prospects and economic benefits for treating inner ear diseases such as deafness, tinnitus and vertigo.

[0040] In addition, it should be noted that, unless otherwise specified, the terms "first", "second", "third", etc. in the specification are only used to distinguish the various components, elements, steps, etc. in the specification, and are not used to indicate the logical relationship or sequential relationship between the various components, elements, steps, etc.

[0041] It is to be understood that, although the present invention has been disclosed as a preferred embodiment, the above embodiment is not intended to limit the present invention. For any person skilled in the art, without departing from the scope of the technical solution of the present invention, the technical content disclosed above can be used to make many possible changes and modifications to the technical solution of the present invention, or modified into equivalent embodiments of equivalent changes. Therefore, any simple modification, equivalent change and modification made to the above embodiments according to the technical essence of the present invention without departing from the content of the technical solution of the present invention still falls within the scope of protection of the technical solution of the present invention.

Claims

1. A microneedle device for precise drug delivery through the external auditory canal tympanic cavity using a cannula inner core, characterized in that include: An elongated outer tube element and an elongated inner core element; wherein, a first protrusion and a second protrusion are formed at the front end of the elongated outer tube element for inserting into the ear, wherein the recessed portion between the first protrusion and the second protrusion is used to limit the position of the tympanic membrane when the first protrusion penetrates the tympanic membrane; and the elongated outer tube element is a hollow structure, which forms a cavity for inserting the elongated inner core element from the rear end to the front end.

2. The microneedle device for precise drug delivery through the external auditory canal tympanic cavity using a cannula inner core according to claim 1, characterized in that: The elongated inner core element has a front tip and a hand-held end; when the elongated inner core element is fully inserted into the elongated outer tube element, the front tip is exposed from the elongated outer tube element.

3. The microneedle device for precise drug delivery through the external auditory canal tympanic cavity using a cannula inner core according to claim 1 or 2, characterized in that: When the long strip inner core element is completely inserted into the long strip outer tube element, the hand-held end contacts the rear end of the long strip outer tube element.

4. The microneedle device for precise drug delivery through the external auditory canal tympanic cavity using a cannula inner core according to claim 1 or 2, characterized in that: The cross-sectional area of ​​the handheld end is designed so that the handheld end cannot be inserted into the rear end of the elongated outer tube element.

5. The microneedle device for precise drug delivery through the external auditory canal tympanic cavity using a cannula inner core according to claim 1 or 2, characterized in that: The elongated inner core element has a cavity for containing medicine, so as to assist in propulsion and achieve drug administration over a longer distance.

6. The microneedle device for precise drug delivery through the external auditory canal tympanic cavity using a cannula inner core according to claim 1 or 2, characterized in that It also includes: a foldable fixing wing located in the ear canal area of ​​the elongated outer tube element when the first protrusion penetrates the eardrum, and is used to fix the position of the elongated outer tube element in the ear canal.

7. The microneedle device for precise drug delivery through the external auditory canal tympanic cavity using a cannula inner core according to claim 6, characterized in that The invention also comprises a control element arranged at the rear end of the elongated outer tube element and used for controlling the opening and folding of the foldable fixed wing.

8. The microneedle device for precise drug delivery through the external auditory canal tympanic cavity using a cannula inner core according to claim 1 or 2, characterized in that: A tee is arranged at the tail end of the long outer tube element; wherein, the first opening of the tee is connected to the hollow structure of the long outer tube element; the opening direction of the second opening of the tee is arranged on a straight line with the opening direction of the first opening, for inserting the long inner core element; the third opening of the tee is used to connect the dosing unit.

9. The microneedle device for precise drug delivery through the external auditory canal tympanic cavity using a cannula inner core according to claim 1 or 2, characterized in that: The first protrusion gradually decreases in cross-sectional area in a direction from back to front so as to penetrate the eardrum.

10. The microneedle device for precise drug delivery through the external auditory canal tympanic cavity using a cannula inner core according to claim 1 or 2, characterized in that: The outer diameter of the long outer tube element is in the range of 0.1 to 0.5 mm, and the inner diameter is in the range of 0.05 to 0.3 mm; the material of the long outer tube element is medical plastic or medical silicone; the material of the long inner core element is medical hard plastic or stainless steel metal material, and the length of the main tube of the long outer tube element is in the range of 4.5 to 10 cm.

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